Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Solution to GAP problem-GettyImages-1874008533

AI Fills The Decision-Making Gaps In Process Analytical Technology

When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.

GUEST COLUMNISTS

FDA Issues New Guidance On Therapeutic Equivalence
The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?
July 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
ADC CDMO Selection For Small Biotech
Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.
Europe's ATMP Opportunity Still Requires Local Navigation
European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.
The Unspoken Truth About Cell Therapy Product Understanding
Developers often discover important attributes after it's too late to act on them. A well-designed program asks what's needed for commercialization and works backward.
Implementing And Optimizing Your eQMS
This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.
Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing
Many small molecule products no longer require massive production. Instead, flexible capacity is needed that can economically produce smaller commercial volumes while maintaining quality and compliance.
CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers
Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.

PHARMA OUTSOURCING WHITE PAPERS

Beyond Particle Counting: Why Modern Biologics Need Particle Forensics
High particle counts don’t always mean high risk. Identifying particle type and origin—not just quantity—avoids false alarms, protects timelines, and turns data into action.

Safely Scaling High Potency API Manufacturing
Scaling HPAPI production demands disciplined containment and exposure control. Integrated operating models help manage risk while enabling compliant, reliable scale‑up.
Control Strategies And Method Development For Nitrosamines In APIs And Drug Products
Explore regulatory insights, analytical strategies, and real-world case studies for effective nitrosamine control in APIs and drug products.
Precision By Design: Drug Innovation Through Structure-Based Drug Design (SBDD)
Leverage structure-based drug design to gain deeper molecular insights, prioritize high-potential candidates, and accelerate your path from discovery to clinic.
Email Etiquette That Actually Saves Time for Pharma & Biotech
Smarter email habits cut wasted time, reduce inbox noise, and improve collaboration. Clear subject lines, careful recipients, and purposeful tool use keep teams focused on meaningful work.
Leveraging Efficiency From CLD To Clinical Manufacturing Of mAbs
Discover how our efficient strategies can propel your mAb from discovery to clinical manufacturing in as little as 18 months.